EzSensor HD

K261663 · Qpix Solutions, Inc. · MUH · Sep 30, 2026 · Dental

Device Facts

• Record ID: K261663
• Device Name: EzSensor HD
• Applicant: Qpix Solutions, Inc.
• Product Code: MUH · Dental
• Decision Date: Sep 30, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Digital intraoral sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

Device Story

Digital intraoral sensor; collects dental x-ray photons; converts to electronic impulses; produces digital images for storage, viewing, and manipulation. Used in dental clinics by dentists. Sensor connects to computer via integrated USB 2.0 module; provides near-instantaneous image acquisition. Ergonomic design improves patient comfort; stainless-steel internal frame; soft silicon exterior for impact protection. Output used by dentists for diagnostic assessment of bony and soft tissue anatomy. Benefits include rapid image acquisition and diagnostic clarity.

Clinical Evidence

Bench testing only. Comparative analysis of clinical sample images between subject and predicate devices confirmed similar contrast, resolution, and anatomical detail (bony and soft tissue). Performance metrics included DQE (0.309), MTF (0.611), and resolution (33.8 lp/mm). Electrical, mechanical, and EMC safety verified per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Indirect conversion digital sensor; CsI scintillator; single crystal Silicon sensing layer. Dimensions: 36.8x25.4mm to 42.9x31.3mm; 4.8mm thickness. Connectivity: Integrated USB 2.0. Materials: Stainless-steel internal frame, soft silicon exterior. Standards: IEC 60601-1:2005/AMD1:2012/AMD2:2020, IEC 60601-1-2:2014+AMD1:2020. Software: Basic level of concern.

Indications for Use

Indicated for dental x-ray imaging in children (2-12 years), adolescents (12-22 years), and adults (22+ years) for diagnostic use by dentists.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• X Sensor (Model: IOS-A151F, HDI-15DGF) (K242778)
• EzSensor HD, EzSensor UHD (K252570)

Reference Devices

• EzDent-i (K241114)

Submission Summary (Full Text)

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**FDA** U.S. FOOD & DRUG
ADMINISTRATION

September 30, 2026

Qpix Solutions, Inc.
% Dave Kim
Medical Device Regulatory Affairs
Mtech Group, LLC
7505 Fannin St.
Suite 610
HOUSTON, TX 77054

Re: K261663

Trade/Device Name: EzSensor HD
Regulation Number: 21 CFR 872.1800
Regulation Name: Extraoral Source X-Ray System
Regulatory Class: Class II
Product Code: MUH
Dated: August 23, 2026
Received: August 24, 2026

Dear Dave Kim:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K261663 - Dave Kim

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Before making any change significantly affecting the safety or effectiveness of the device, you must submit a new premarket notification in accordance with 21 CFR 807.81. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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K261663 - Dave Kim

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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-ray Systems Team
DHT8B: Division of Radiologic Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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# Indications for Use

| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K261663 | ? |
| --- | --- | --- | --- |
| Please provide the device trade name(s). | | | ? |
| EzSensor HD | | | |
| Please provide your Indications for Use below. | | | ? |
| Digital intraoral sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists. | | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☑ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | | ? |

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510(k) Submission – EzSensor HD (IOS-U20IF, IOS-U15IF, IOS-U10IF)

# 1. 510(k) Summary : K261663

This summary of 510(k) substantial equivalence information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date 510K summary prepared: August 21, 2026

Submitter's Name, address, telephone number, a contact person:

Submitter's Name : Qpix Solutions Inc

Submitter's Address: 1001 Aviation Parkway, Ste 200, Morrisville, North Carolina, 27560 USA

Submitter's Telephone: [phone]

Contact person: Mr. Richard Jeon / CEO / [phone]

Official Correspondent: Dave Kim ([e-mail])

Address: 7505 Fannin St. Suite 610, Houston, TX 77054

Telephone: [phone]

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

Trade/proprietary name: EzSensor HD

Model Name: IOS-U20IF, IOS-U15IF, IOS-U10IF

Common Name: Digital Dental Intra Oral Sensor

Regulation number: 21 CFR 872.1800

Classification Name: Extraoral source X-ray system

Regulatory Class: Class 2

Product Code: MUH

Predicate Device

Manufacturer: Qpix Solutions Inc

Device Name: X Sensor (Model: IOS-A151F, HDI-15DGF)

510(k) Number: K242778

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510(k) Submission – EzSensor HD (IOS-U20IF, IOS-U15IF, IOS-U10IF)

| Regulation Number: | 21 CFR 872.1800 |
| --- | --- |
| Classification Name: | Extraoral Source X-ray System |
| Regulatory Class: | Class 2 |
| Product Code: | MUH |

# Second Predicate Device

| Manufacturer: | Qpix Solutions Inc |
| --- | --- |
| Device Name: | EzSensor HD, EzSensor UHD |
| 510(k) Number: | K252570 |
| Regulation Number: | 21 CFR 872.1800 |
| Classification Name: | Extraoral Source X-ray System |
| Regulatory Class: | Class 2 |
| Product Code: | MUH |

# 2. Device Description

EzSensor HD is a digital intraoral sensor which acquires intra oral images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of Indirect sensor systems is the speed with which images are acquired. The ergonomic design based on human intraoral anatomy improves patient comfort. EzSensor HD includes the software (firmware) with basic level of concern.

# 3. Indication for use

Digital intraoral sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

# 4. Summary of Design Control Risk management

The risks and the hazardous impact of the device modification were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented in the new product design phase. The overall assessment concluded that all risks and hazardous conditions identified arising from the design change were successfully mitigated and accepted.

# 5. Summary of the technological characteristics of the device compared to the predicate device

Digital intraoral sensor described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device. These differences do not raise the questions of safety or effectiveness. Based on the laboratory testing results submitted in this 510k, we conclude that the subject device is

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510(k) Submission – EzSensor HD (IOS-U20IF, IOS-U15IF, IOS-U10IF)

substantially equivalent to the predicate device.

The potential risks for a new sensor size were analyzed by conducting complete verification for IEC 60601-1 and drop & vibration test which included electronic shock, leakage current, etc.

While applying the stainless-steel material to the inside of the frame, soft silicon material surrounds the exterior of the USB connector to protect the sensors from a potential external impact. Additional risk analysis was conducted to mitigate the potential risks that may arise with respect to leakage current, sensor fracture or breakage, and cable disconnection. The risk mitigation measures were satisfactory to manage the new risks identified and the residual risks were within acceptable limits.

| Characteristic | Proposed | First Predicate Device |
| --- | --- | --- |
| Manufacturer | Qpix solutions Inc | Qpix solutions Inc |
| Device's name | EzSensor HD(Model: IOS-U20IF, IOS-U15IF, IOS-U10IF) | X Sensor(Model: IOS-A15IF, HDI-15DGF) |
| Feature |  |  |
| 510(k) number | K261663 | K242778 |
| X-ray converter | CsI | CsPbBr3 |
| Indications for use | Digital Dental Intra Oral Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists. | Digital Dental Intra Oral Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists. |
| Sensor Dimension (mm) (±10%) | Size 1.0: 1.44 x 1.00 x 0.19 inch (36.8x25.4x4.8 mm)Size 1.5: 1.55 x 1.15 x 0.19 inch (39.5x29.2x4.8 mm)Size 2.0: 1.69 x 1.28 x 0.19 inch (42.9x31.3x4.8 mm) | Size 1.5: 41.1 x 30.4 |
| Sensor Thickness (mm) | 4.8 | 4.8 |
| Active Area (mm) | Size 1.0: 1014 x 676 pixels (30.01 x 20.01 mm)2028 x 1352 pixels @high resolution modeSize 1.5: 1115 x 810 pixels (33.00 x 23.98 mm)2230 x 1620 pixels @high resolution modeSize 2.0: 1216 x 878 pixels (35.99 x 25.99 mm)2432 x 1756 pixels @high resolutions mode | Size 1.5: 23.98 x 33.00 |
| USB Module | Integrated USB 2.0 module | Integrated USB 2.0 module |

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510(k) Submission – EzSensor HD (IOS-U20IF, IOS-U15IF, IOS-U10IF)

| Max. Resolution (lp/mm) | 33.78 lp/mm (theoretical) | | 33.8 |
| --- | --- | --- | --- |
| Pixel Pitch(μm) | Full Resolution | 14.8 | 14.8 |
| DQE(6 lp/mm) | Full Resolution | 0.309 | 0.278 |
| MTF(3 lp/mm) | Full Resolution | 0.611 | 0.716 |
| Viewer Software | EzDent-i (K241114) | | EzDent-i (K241114) |

| Characteristic | | Proposed | Second Predicate Device |
| --- | --- | --- | --- |
| Manufacturer | | Qpix solutions Inc | Qpix solutions Inc |
| Device's name | | EzSensor HD(Model: IOS-U20IF, IOS-U15IF, IOS-U10IF) | EzSensor HD, EzSensor UHD(Model: IOS-U20IF, IOS-U15IF, IOS-U10IF) |
| Feature | |  |  |
| 510(k) number | | K261663 | K252570 |
| X-ray converter | | CsI | CsI |
| Indications for use | | Digital Dental Intra Oral Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists. | Digital Dental Intra Oral Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists. |
| Sensor Dimension(mm) (±10%) | | Size 1.0: 36.8x25.4 mmSize 1.5: 39.5x29.2 mmSize 2.0: 42.9x31.3 mm | Size 1.0: 36.8x25.4 mmSize 1.5: 39.5x29.2 mmSize 2.0: 42.9x31.3 mm |
| Sensor Thickness(mm) | | 4.8 | 4.8 |
| Active Area(mm) | | Size 1.0: 30.01 x 20.01 mm2028 x 1352 pixels @high resolution modeSize 1.5: 33.00 x 23.98 mm2230 x 1620 pixels @high resolution modeSize 2.0: 35.99 x 25.99 mm2432 x 1756 pixels @high resolutions mode | Size 1.0: 30.01 x 20.01Size 1.5: 33.00 x 23.98Size 2.0: 35.99 x 25.99 |
| USB Module | | Integrated USB 2.0 module | Integrated USB 2.0 module |
| Max. Resolution (lp/mm) | | 33.8 | 33.8 |
| Pixel Pitch | Full | 14.8 | 14.8 |

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510(k) Submission – EzSensor HD (IOS-U20IF, IOS-U15IF, IOS-U10IF)

| (μm) | Resolution | | |
| --- | --- | --- | --- |
| DQE (6 lp/mm) | Full Resolution | 0.309 | 0.278 |
| MTF (3 lp/mm) | Full Resolution | 0.611 | 0.668 |
| Viewer Software | | EzDent-i (K241114) dental imaging viewer by EWOO SOFT | EzDent-i (K241114) dental imaging viewer by EWOO SOFT |

## 6. Summary of Performance Testing

The intended use, application of EzSensor HD is the same as that of the predicate device, X Sensor (K242778) and EzSensor HD / UHD (K252570).

EzSensor HD is an indirect conversion sensor that utilizes a photoconductor (CsI) and single crystal Silicon as the sensing means whereas X Sensor, the predicate device, utilizes a photoconductor(CsPbBr3) and single crystal Silicon as the sensing means.

Furthermore, EzSensor HD has the same scintillator as the second predicate device, EzSensor HD / UHD (K252570)

The performance test result indicates that the EzSensor HD intra oral sensor performed equally to the X Sensor, the predicated device, as both sensors have the same pixel pitch, thereby providing the same maximum line-pair resolution. No additional safety risk is identified in the bench test: Non-clinical report.

Non-clinical test was performed according to FDA Guidance “Guidance for the Submissions of 510(k)’s for Solid State X- ray Imaging Devices”.

Due to differences in the utilization a photoconductor between the EzSensor HD CsI and the predicate device X Sensor CsPbBr3, there is a slight variation in EzSensor HD MTF(0.611) for X Sensor MTF(0.716). However, this difference does not affect their practical equivalence performance.

DQE, MTF, and NPS test results demonstrated that EzSensor HD has equivalent performance outcome than X Sensor, the predicate sensor.

Electrical, mechanical, environmental safety and performance testing were performed according to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 (Medical electrical equipment Part 1:General requirements for basic safety and essential performance). EMC testing was conducted in accordance with standard IEC 60601-1-2:2014+AMD1:2020.

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510(k) Submission – EzSensor HD (IOS-U20IF, IOS-U15IF, IOS-U10IF)

The clinical sample images of the EzSensor HD sensor and X Sensor were reviewed comparatively.

The image quality in terms of contrast and resolution is overall similar for EzSensor HD, the subject device and the X sensor, EzSensor HD / UHD, the predicate devices.

There are no observable radiographic findings and no quality issues with intra oral diagnostic images provided by both sensors.

In conclusion, both digital intra oral sensors provide adequate anatomical details including edge definition and grayscale of bony and soft tissue images.

# 7. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Qpix Solutions Inc concludes EzSensor HD is substantially equivalent to the predicate device as described herein.

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